Analyte Monitoring Devices and Methods Therefor

ABSTRACT

Method and apparatus for performing a discrete glucose testing and bolus dosage determination including a glucose meter with bolus calculation function are provided.

RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 14/094,713, now U.S. Pat. No. 9,039,975, which is acontinuation of U.S. patent application Ser. No. 13/556,142 filed Jul.23, 2012, now U.S. Pat. No. 8,597,575, which is a continuation of U.S.patent application Ser. No. 11/396,182 filed Mar. 31, 2006, now U.S.Pat. No. 8,226,891, entitled “Analyte Monitoring Devices and MethodsTherefor”, the disclosures of each of which are incorporated herein byreference for all purposes.

BACKGROUND OF THE INVENTION

In diabetes management, there exist devices which allow diabeticpatients to measure the blood glucose levels. One such device is ahand-held electronic meter such as a blood glucose meter such asFreestyle® blood glucose monitoring system available from AbbottDiabetes Care Inc., of Alameda, Calif. which receives blood samples viaenzyme-based test strips. Typically, the patient lances a finger oralternate body site to obtain a blood sample, applies the drawn bloodsample to the test strip, and the strip is inserted into a test stripopening or port in the meter housing. The blood glucose meter converts acurrent generated by the enzymatic reaction in the test strip to acorresponding blood glucose value which is displayed or otherwiseprovided to the patient to show the level of glucose at the time oftesting.

Such periodic discrete glucose testing helps diabetic patients take anynecessary corrective actions to better manage diabetic conditions.Presently available glucose meters have limited functionalities (forexample, providing the glucose value measured using the test strip andstoring the data for subsequent recall or display) and do not provideany additional information or capability to assist patients in managingdiabetes. For example, Type-1 diabetic patients who require periodicinfusion or injection of insulin, typically use glucose meters inaddition to, for example, wearing an external infusion device, or a pentype injection device. Also, in the case of external infusion devices,because of the strip port on the meter receives the test strip (which isgenerally not a water tight seal), it is not desirable to incorporatethe discrete glucose meter functionalities to the housing of theexternal infusion devices.

With the decreasing cost of electronic components and a correspondingincrease in data processing capabilities of microprocessors,computational capability of electronic devices has been rapidlyincreasing. However, currently available glucose meters are generallyconfigured with limited functionalities related to discrete glucosetesting. In view of the foregoing, it would be desirable to have aglucose meter, such as a blood glucose meter, with variousfunctionalities. Of interest are glucose meters that are capable ofproviding bolus dosage calculation, and the like, and which incorporateadditional features related to diabetes management.

SUMMARY OF THE INVENTION

In view of the foregoing, in accordance with the various embodiments ofthe present invention, there are provided methods and system forincorporating the bolus calculation function into a blood glucose meterdevice which may be configured to perform data analysis and managementbased on, for example, the glucose level detected using the glucosemeter.

These and other objects, features and advantages of the presentinvention will become more fully apparent from the following detaileddescription of the embodiments, the appended claims and the accompanyingdrawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a glucose meter with bolus calculation function in accordancewith one embodiment of the present invention;

FIG. 2 is a block diagram of the glucose meter with bolus calculationfunction of FIG. 1 in one embodiment of the present invention;

FIG. 3 is a flowchart illustrating the glucose level determination andbolus calculation procedure in accordance with one embodiment of thepresent invention;

FIG. 4 is a flowchart illustrating the bolus calculation procedure ofFIG. 3 in accordance with one embodiment of the present invention; and

FIG. 5 is a flowchart illustrating the glucose level determination andbolus calculation procedure in accordance with another embodiment of thepresent invention.

DETAILED DESCRIPTION

As described in further detail below, in accordance with the variousembodiments of the present invention, there are provided blood glucosemeter devices that include bolus calculation functions and related dataanalysis capabilities incorporated in the glucose meter devices.

FIG. 1 shows a glucose meter with bolus calculation function inaccordance with one embodiment of the present invention. Glucose meterwith bolus calculation function 100 includes a housing 110 with adisplay unit 120 provided thereon. Also shown in FIG. 1 is a pluralityof input buttons 130, each configured to allow the user of the glucosemeter with bolus calculation function 100 to input or enter data orrelevant information associated with the operation of the glucose meterwith bolus calculation function 100. For example, the user of theglucose meter with bolus calculation function may operate the one ormore input buttons 130 to enter a calibration code associated with atest strip 160 for use in conjunction with the glucose meter with boluscalculation function 100. Additionally, the user may operate the one ormore input buttons 130 to adjust time and/or date information, as wellas other features or settings associated with the operation of theglucose meter with bolus calculation function 100.

Referring back to FIG. 1, also shown is input unit 140 which, in oneembodiment, may be configured as a jog dial, or the like, and providedon the housing 110 of the glucose meter with bolus calculation function100. In one embodiment, as discussed in further detail below, the useror the patient may operate the input unit 140 to perform calculationsand determinations associated with one or more bolus estimation functionof the glucose meter with bolus calculation function 100. Also shown inFIG. 1 is a strip port 150 which is configured to receive the test strip160 (with blood sample provided thereon) substantially in the directionas shown by the directional arrow 170.

In operation, when the test strip 160 with the patient's blood sample isinserted into the strip port 150 of the glucose meter with boluscalculation function 100, a micro processor or a control unit 210 (FIG.2) of the glucose meter with bolus calculation function 100 may beconfigured to determine the associated glucose level in the bloodsample, and display the determined glucose level on the display unit120.

In addition, in accordance with the various embodiments of the presentinvention, the glucose meter with bolus calculation function 100 may beconfigured to automatically enter into a bolus determination mode to,for example, estimate the predetermined or pre-programmed bolus dosageamount based on information stored in the glucose meter with boluscalculation function 100 (such as the patient's insulin sensitivity, forexample), and/or prompt the patient to provide additional information,such as the amount of carbohydrate to be ingested by the patient fordetermination of, for example, a carbohydrate bolus dosagedetermination. The patient may operate the input unit 140 in conjunctionwith the user interface menu provided on the display unit 120 to providethe appropriate information.

In another embodiment, the glucose meter with bolus calculation function100 may be configured to prompt the patient to select whether tocalculate a predetermined or preprogrammed bolus dosage amount such as,for example, a correction bolus or a carbohydrate bolus, following thedisplay of the determined glucose level from the test strip 160. In thismanner, in one embodiment of the present invention, the glucose meterwith bolus calculation function 100 may be configured to automaticallyprompt the user or patient to select whether a bolus dosagedetermination is desired following a glucose testing using the teststrip 160.

FIG. 2 is a block diagram of the glucose meter with bolus calculationfunction of FIG. 1 in one embodiment of the present invention. Referringto FIG. 2, the glucose meter with bolus calculation function 200includes a controller unit 210 operatively coupled to a communicationinterface 220 and configured for bidirectional communication. Thecontroller unit 210 is further operatively coupled to a test stripinterface 230, an input section 240 (which, for example, may include theinput unit 140 and the plurality of input buttons 130 as shown in FIG.1), an output unit 250, and a data storage unit 260.

Referring to FIG. 2, in one embodiment of the present invention, thetest strip interface 230 is configured to couple with the inserted teststrip 160 for determination of the blood sample on the test strip 160.In addition, the test strip interface 230 may include an illuminationsegment which may be configured to illuminate the strip port 150(FIG. 1) using a light emitting diode (LED), for example, during thetest strip 160 insertion process to assist the user in properly andaccurately inserting the test strip 160 into the strip port 150.

Moreover, in a further aspect of the present invention, the test stripinterface 230 may be additionally configured with a physical latch orsecurement mechanism internally provided within the housing 110 of theglucose meter with bolus calculation function 100 (FIG. 1) such thatwhen the test strip 160 is inserted into the strip port 150, the teststrip 160 is retained in the received position within the strip port 150until the sample analysis is completed. Examples of such physical latchor securement mechanism may include a uni-directionally biased anchormechanism, or a pressure application mechanism to retain the test strip160 in place by applying pressure on one or more surfaces of the teststrip 160 within the strip port 150.

Referring back to FIG. 1, the output unit 250 may be configured tooutput display data or information including the determined glucoselevel on the display unit 120 (FIG. 1) of the glucose meter with boluscalculation function 100. In addition, in still a further aspect of thepresent invention, the output unit 250 and the input section 240 may beintegrated, for example, in the case where the display unit 120 isconfigured as a touch sensitive display where the patient may enterinformation or commands via the display area using, for example, astylus or any other suitable input device, and where, the touchsensitive display is configured as the user interface in an icon drivenenvironment, for example.

Referring yet again to FIG. 2, the communication interface 220 in oneembodiment of the present invention includes a wireless communicationsection configured for bi-directional radio frequency (RF) communicationwith other devices to transmit and/or receive data to and from theglucose meter with bolus calculation function 100. In addition, thecommunication interface 220 may also be configured to include physicalports or interfaces such as a USB port, an RS-232 port, or any othersuitable electrical connection port to allow data communication betweenthe glucose meter with bolus calculation function 100 and other externaldevices such as a computer terminal (for example, at a physician'soffice or in hospital environment), an external infusion device such asinsulin pumps, or other devices that is configured for similarcomplementary data communication.

In one embodiment, the wireless communication section of thecommunication interface 220 may be configured for infraredcommunication, Bluetooth® communication, or any other suitable wirelesscommunication mechanism to enable the glucose meter with boluscalculation function to communication with other devices such asinfusion devices, analyte monitoring devices, computer terminals,communication enabled mobile telephones, personal digital assistants, orany other communication devices which the patient or user of the glucosemeter with bolus calculation function 100 may use in conjunctiontherewith, in managing the treatment of the diabetic condition.

FIG. 3 is a flowchart illustrating the glucose level determination andbolus calculation procedure in accordance with one embodiment of thepresent invention. Referring to FIG. 3, a test strip is detected by thecontroller unit 210 (or the test strip interface 230) 310 of the glucosemeter with bolus calculation function 100 (FIG. 1). Thereafter, theblood sample received from the inserted test strip 150 is analyzed 320to determine the corresponding glucose level, and the determined glucoselevel is output 330 on the display unit 120 (FIG. 1) for example, inunits of mg/dL.

Referring back to FIG. 3, after determining the glucose level anddisplaying the measured glucose level to the patient 330, a promptcommand is generated and output to the patient to select if the boluscalculation is desired 340. More specifically, in one embodiment of thepresent invention, the controller unit 210 is configured to generate acommand and display in the display unit 120 to query the user as towhether a bolus calculation determination is desired by the patient.Thereafter, a determination of whether or not the patient has selectedto have the bolus dosage calculation performed by the controller unit210 is made 350. In one embodiment, the patient may operate one or moreof the input buttons 130 or the input unit 140 to select whether or notto have the bolus calculation performed.

Referring again to FIG. 3, if it is determined that the patient hasselected not to have the bolus dosage determination performed, then thedetermined glucose value is stored 360, e.g., in memory of the meter,and the routine terminates. For example, in one embodiment, thecontroller unit 210 (FIG. 2) may be configured to store the determinedglucose value in the data storage unit 260 with associated time and/ordate information of when the glucose value determination is performed.In an alternate embodiment, the measured glucose value may be storedsubstantially concurrently with the display of the glucose value (forexample, 330).

On the other hand, if it is determined that the patient has selected tohave the bolus dosage calculation performed, the glucose meter withbolus calculation function 100 is configured to enter the bolus dosagedetermination mode 370, described in further detail below in conjunctionwith FIG. 4, where the desired type of bolus dosage is determined andprovided to the patient.

FIG. 4 is a flowchart illustrating the bolus calculation procedure ofFIG. 3 in accordance with one embodiment of the present invention.Referring to FIG. 4, when the glucose meter with bolus calculationfunction 100 (FIG. 1) enters the bolus dosage determination mode asdescribed above, the controller unit 210 (FIG. 2) is configured toprompt the patient (for example, by displaying the options to thepatient on the display unit 120 (FIG. 1)) to select the type of desiredbolus dosage calculation 410. For example, the controller unit 210 maybe configured to output a list of available bolus dosage calculationoptions including, for example, a carbohydrate bolus, a correctionbolus, a dual or extended bolus, a square wave bolus, or any othersuitable bolus calculation function which may be programmed into theglucose meter with bolus calculation function 100 (and for example,stored in the data storage unit 260).

Referring back to FIG. 4, after the patient selects the desired bolusdosage calculation in response to the prompt for bolus type selection410, the selected bolus dosage calculation routine is retrieved 420 fromthe data storage unit 260, thereafter executed 430. In one embodiment,the execution of the selected bolus dosage calculation 430 may includeone or more input prompts to the patient to enter additional informationas may be required to perform the selected bolus dosage calculation.

For example, in the case of calculating a carbohydrate bolus, thepatient may be prompted to provide or enter an estimate of thecarbohydrate amount that the patient is planning on ingesting 430. Inthis regard, a food database may be stored in the data storage unit 260or elsewhere for easy access (e.g., a PC, PDA, telephone, or the likeand to which the meter may be coupled (e.g., wirelessly or by physicalconnection) to easily retrieve such information) to convenientlydetermine the corresponding carbohydrate amount associated with the typeof food which the patient will be ingesting. Alternatively, the patientmay provide the actual estimated carbohydrate count if such informationis readily available by the patient.

Alternatively, in the case of calculating a dual bolus, the patient isprompted to provide a time duration information for the extended portionof the bolus dosage to be infused or otherwise provided to the patient.Similarly, the patient may further be prompted to provide insulinsensitivity information, and any other information as maybe necessary todetermine the selected bolus dosage amount in conjunction with otherrelevant information such as insulin on board information, and the timeof the most recently administered bolus (so as to provide a warning tothe patient if a bolus dosage has been administered within apredetermined time period, and a subsequent administration of theadditional bolus dosage may potentially be harmful).

Referring back to FIG. 4, after the execution of the selected bolusdosage calculation routine 430, the calculated bolus dosage amount isstored 440 in the data storage unit 260, and the calculated bolus dosageamount is output displayed to the patient 450 on the display unit 120 ofthe glucose meter with bolus calculation function 100, or audibly if themeter is so configured. In certain embodiments, storing and outputdisplaying the calculated bolus dosage amount may be substantiallyconcurrently performed, rather than sequentially.

FIG. 5 is a flowchart illustrating the glucose level determination andbolus calculation procedure in accordance with another embodiment of thepresent invention. Referring to FIG. 5, a test strip 160 is insertedinto the strip port of the glucose meter with bolus calculation function510, the blood sample on the test strip 160 is analyzed to determine thecorresponding blood glucose level 520, and thereafter, output displayed530.

Referring back to FIG. 5, a determination of the blood glucose levelfrom the blood sample received from the test strip 160, is made 540. Thecontroller unit 210 (FIG. 2) is configured to enter into the bolusdosage determination mode, and to execute pre-programmed orpredetermined bolus calculation routine 550, and thereafter, outputdisplay the calculated bolus dosage amount 560. In this manner, in oneembodiment of the present invention, the glucose meter with boluscalculation function 100 may be programmed or configured toautomatically enter into the dosage determination mode upon completionof the blood sample analysis for glucose level determination.

In one embodiment of the present invention, the glucose meter with boluscalculation function 100 may be configured to execute different types ofbolus dosage calculation based on the patient specified parameters. Forexample, the glucose meter with bolus calculation function 100 may beconfigured to perform a carbohydrate bolus determination when the teststrip sample analysis is performed within a predetermined time period ofa meal event. For example, the glucose meter with bolus calculationfunction 100 may be programmed by the patient to automatically selectthe carbohydrate bolus determination if the test strip blood sampleanalysis is performed within one hour prior to a meal time (which may beprogrammed into the glucose meter with bolus calculation function 100).

Accordingly, as described herein, embodiments of the present invention,method and apparatus for performing discrete glucose testing and bolusdosage determination are provided.

An apparatus including a glucose meter in one embodiment of the presentinvention includes a housing having a display unit disposed thereon, astrip port coupled to the housing and a controller unit coupled to thehousing, a controller configured to process one or more signalsassociated with data received from the test strip, and a controller (thesame or different controller from the controller described above)configured to determined a bolus dosage based on the data received fromthe test strip.

The controller may be configured to display the determined bolus dosageon the display unit, where the displayed bolus dosage may be one or moreof an alphanumeric display, a graphical display, a video display, anaudio display, a vibratory output, or combinations thereof

In a further aspect, the controller unit may be configured to determinethe bolus dosage substantially automatically after receiving the datafrom the test strip.

In one embodiment, the apparatus may include an output unit configuredto provide one or more of an audible notification, a vibratorynotification, or combinations thereof.

Moreover, the bolus dosage determined by the controller unit may includeone or more of a carbohydrate bolus, a correction bolus, an extendedbolus, a dual bolus, or combinations thereof

The apparatus in yet another embodiment may include an input unitcoupled to the housing, where the controller unit may be configured todetermine the bolus dosage in response to a command received from theinput unit.

The input unit may include one or more of an input button, a touchsensitive screen, a jog wheel, or combinations thereof.

Further, the data received from the test strip may correspond to ananalyte level which, in one embodiment may include a measured glucoselevel of a patient.

A computer program product for use with a glucose meter in accordancewith a further embodiment of the present invention includes a computerreadable storage medium having a computer program stored thereon whichcontrols the meter to calculate a bolus dosage based on glucoseinformation received from the meter.

In one aspect, the glucose meter may be configured to display thecalculated bolus dosage. The bolus dosage displayed on the glucose metermay be one or more of an alphanumeric display, a graphical display, avideo display, an audio display, a vibratory output, or combinationsthereof

In a further aspect, the bolus dosage may include one or more of acarbohydrate bolus, a correction bolus, an extended bolus, a dual bolus,or combinations thereof.

Also provided are methods of analyte monitoring. Embodiments includereceiving an analyte sample, determining an analyte level correspondingto the analyte sample, and determining a bolus dosage amountsubstantially immediately after the analyte level determination.

In one embodiment, the method may include displaying one or more of thebolus dosage, the analyte level, or combinations thereof. Determining abolus dosage in some embodiments may be automatically performed afterthe analyte level determination.

The method may include generating one or more of an audiblenotification, a vibratory notification, a visual notification, orcombinations thereof, associated with one or more of the determinedbolus dosage, the determined analyte level, or combinations thereof

The bolus dosage determined in one embodiment may include one or more ofa carbohydrate bolus, a correction bolus, an extended bolus, a dualbolus, or combinations thereof

The various processes described above including the processes performedby the processor unit 210 in the software application executionenvironment of the glucose meter device 200 including the processes androutines described in conjunction with FIGS. 3-5, may be embodied ascomputer programs developed using an object oriented language thatallows the modeling of complex systems with modular objects to createabstractions that are representative of real world, physical objects andtheir interrelationships. The software required to carry out theinventive process, which may be stored in the storage unit 260 (FIG. 2)of the glucose meter with bolus calculation function 100, may bedeveloped by a person of ordinary skill in the art and may include oneor more computer program products.

A computer program product is also provided that is configured for usewith a glucose meter. The program product includes a computer readablestorage medium having a computer program stored thereon for calculatinga bolus based on glucose information from the meter. For example, ameter controller may include a general purpose digital microprocessor orthe like that may be programmed from such a computer readable mediumcarrying necessary program code for accomplishing the bolus functiondescribed herein. The programming may be provided remotely to the metercontroller, e.g., through a communication channel, or previously savedin a computer program product such as memory or some other portable orfixed computer readable storage medium. For example, a magnetic oroptical disk may carry the programming, which may be read by a reader ofthe meter and optionally stored in the meter memory of the meter. Thecomputer program product may be any suitable product, such as a portableor fixed computer readable storage medium, including magnetic or opticaldisks or tape or RAM, or any other suitable device, either fixed orportable.

Various other modifications and alternations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments.

What is claimed is:
 1. An apparatus, comprising: a housing including a strip port; and a controller unit disposed in the housing, the controller configured to determine when an analyte test strip is received in the strip port within a predetermined time period of a meal event, and to automatically select a bolus determination mode to determine a bolus dosage.
 2. The apparatus of claim 1, further including an output unit coupled to the housing, wherein the controller unit is further configured to output the determined bolus dosage on the output unit.
 3. The apparatus of claim 1, wherein the determined bolus dosage includes one or more of a carbohydrate bolus, a correction bolus, an extended bolus, a dual bolus, or one or more combinations thereof.
 4. The apparatus of claim 1, further including an input unit coupled to the housing, wherein the controller unit is configured to determine the bolus dosage in response to one or more inputs received from the input unit.
 5. The apparatus of claim 4, wherein the one or more inputs include insulin sensitivity information, amount of carbohydrate to be ingested, or a type of bolus dosage.
 6. The apparatus of claim 1, wherein the controller unit is further configured to determine an analyte level from an analyte sample on the analyte test strip received in the strip port.
 7. The apparatus of claim 6, wherein the determined analyte level includes one or more of a glucose level or a ketone level.
 8. The apparatus of claim 1, further including a data communication unit disposed in the housing and configured for one of uni-directional data communication or bi-directional data communication.
 9. The apparatus of claim 8, wherein the data communication unit is configured to receive one or more signals associated with a monitored analyte level from an analyte sensor.
 10. The apparatus of claim 9, wherein the analyte sensor includes at least one working electrode including an analyte-responsive enzyme bonded to a polymer disposed on the working electrode.
 11. A method, comprising: detecting when an analyte test strip is received in a strip port; and automatically selecting a bolus determination mode to determine a bolus dosage when the analyte test strip is received in the strip port within a predetermined time period of a meal event.
 12. The method of claim 11, further including outputting the determined bolus dosage on an output unit.
 13. The method of claim 12, further including outputting one or more of a visual output, an audible output, a tactile output, or one or more combinations thereof.
 14. The method of claim 11, wherein the determined bolus dosage includes one or more of a carbohydrate bolus, a correction bolus, an extended bolus, a dual bolus, or one or more combinations thereof.
 15. The method of claim 11, further including receiving one or more inputs, wherein the bolus dosage is determined in response to the received one or more inputs.
 16. The method of claim 15, wherein the one or more inputs include insulin sensitivity information, amount of carbohydrate to be ingested, or a type of bolus dosage.
 17. The method of claim 11, further including determining an analyte level from an analyte sample on the analyte test strip received in the strip port.
 18. The method of claim 17, wherein the determined analyte level includes one or more of a glucose level or a ketone level.
 19. The method of claim 11, further including receiving one or more signals associated with a monitored analyte level from an analyte sensor.
 20. The method of claim 19, wherein the analyte sensor includes at least one working electrode including an analyte-responsive enzyme bonded to a polymer disposed on the working electrode. 